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NCT02079090
Ketofol Versus Fentofol for Procedural Sedation of Children 3 to 17 Years Old: a Double-Blind Randomized Controlled Trial
Phase 3 trial testing Ketofol in Emergency Department Procedural Sedation in 30 participants. Completed in 1 June 2017.
1 June 2017
Quick facts
| Lead sponsor | University of British Columbia |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 1 July 2014 |
| Primary completion | 1 June 2017 |
| Estimated completion | 1 June 2017 |
| Sites | 1 location across Canada |
Drugs / interventions tested
Conditions studied
- Emergency Department Procedural Sedation — all drugs for Emergency Department Procedural Sedation →
- Fracture Reduction — all drugs for Fracture Reduction →
Sponsor
University of British Columbia
Who can join
Adults 3 to 17, any sex, with Emergency Department Procedural Sedation or Fracture Reduction. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Duration of Sedation
Time frame: Less than 30 minutes
Duration of sedation is measured from time of administration of Propofol (time 0) to recovery being achieved.
Sponsor's own description
Sedation and pain medication is required when bone fractures need to be fixed in the emergency department (ED). Many drugs have been used safely as single agents or in combination for the sedation of children. These drugs include Propofol, Ketamine and Fentanyl. However each of these medications has side effects and drawbacks. The combination of Propofol and Fentanyl (Fentofol) has never been compared directly with the combination of Propofol and Ketamine (Ketofol) for painful procedures in the ED, and the goal of this study is to determine which combination works better. The primary outcome of this study is to determine which drug combination has a shorter time from onset of sedation to full recovery. The investigators hypothesize that Fentofol will have shorter sedation to recovery times.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT02079090
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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- NCT05655754 — Comparison of Esketamine/Propofol and Methohexital Anesthesia for ECT · Phase 4 · recruiting
- NCT02643979 — Ketamine and Propofol Combination Versus Propofol for Upper Gastrointestinal Endoscopy · Phase 4 · terminated
Other University of British Columbia trials
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02079090 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of British Columbia
- Last refreshed: 25 October 2017
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02079090.
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